Core Insights - SeaStar Medical Holding Corporation announced positive preliminary results from the SAVE Surveillance Registry, highlighting the effectiveness of QUELIMMUNE therapy for critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2] Group 1: Clinical Results - The first 21 pediatric patients treated with QUELIMMUNE therapy showed zero device-related adverse events or infections, with a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 [2][3] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [3] - For pediatric survivors without a history of end-stage renal disease (ESRD) or recent kidney transplant, 75% were dialysis-free at Day 28, and 82% at Day 90 [3] Group 2: Therapy Overview - QUELIMMUNE therapy is designed for children with AKI and sepsis, weighing 10 kilograms or more, and is administered in conjunction with Renal Replacement Therapy (RRT) [8] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, which can lead to organ failure [11] - QUELIMMUNE therapy was approved under a Humanitarian Device Exemption in February 2024, requiring participation in the SAVE Surveillance Registry for data collection [8] Group 3: Future Implications - The SAVE Surveillance Registry aims to confirm the safety and efficacy of QUELIMMUNE therapy, with plans to collect data from up to 300 patients [4] - Initial results from the registry are expected to support broader adoption of QUELIMMUNE therapy and inform payer discussions [4] - SeaStar Medical is also conducting a pivotal clinical trial (NEUTRALIZE-AKI) for adult patients with AKI requiring continuous renal replacement therapy [12]